Zydus Lifesciences’ Desidustat Tablets NDA Accepted by China’s NMPA

On April 23, 2024, Zydus Lifesciences Limited informed in an exchange filing that the New Drug

Application (NDA) of Desidustat Tablets has been accepted by the National Medical Products Administration of China (NMPA).

CMS International Development and Management Limited, a wholly-owned subsidiary of China

Medical System Holdings Limited (CMS) obtained an exclusive licence for the Desidustat Tablets from Zydus Lifesciences in 2020.

Regarding the tablets, the company stated that Desidustat, administered orally, is a novel, oral Hypoxia-Inducible Factor-Prolyl Hydroxylase Inhibitor (HIF-PHI) to treat anaemia in Chronic Kidney Disease (CKD) patients. CKD involves the gradual loss of functioning of kidneys and eventually leads to kidney failure. Healthy kidneys naturally secrete a hormone called Erythropoietin (EPO), which stimulates red blood cell production also known as erythropoiesis.

When kidneys are impaired, such as in patients suffering from chronic kidney disease, EPO production is impaired, leading to the development of anaemia. HIF-PHI promotes erythropoiesis by increasing endogenous erythropoietin, reducing hepcidin, and thereby enhancing iron availability.

Desidustat was discovered and developed by Zydus Lifesciences and is being marketed by the group in India under the brand name Oxemia™. China Medical System Holdings Limited, through its wholly-owned subsidiary, gained a royalty-bearing, exclusive, sub-licensable licence under the licensed technology and Zydus Lifesciences data to develop, register, manufacture, use, and commercialise the tablets in Greater China, including Hong Kong Special Administrative Region, Mainland China, Taiwan and Macao Special Administrative Region.

Commenting on the development, the Managing Director of Zydus Lifesciences, Dr Sharvil Patel, stated, “We are excited about the NDA acceptance of Desidustat in China by NMPA. Our life-changing discoveries are guided by the need to help patients and empower them with therapies that enable them to live healthier and more fulfilled lives. We believe this collaboration with CMS will accelerate the development and commercialisation process of Desidustat in Greater China”.

Zydus Lifesciences further added that Desidustat tablets are administered orally, thus hoping to enhance patients’ treatment compliance and meet the unmet treatment requirements in the CKD anaemia field, including dialysis and non-dialysis patients.

On April 23, 2024, the share price of Zydus Lifesciences Ltd opened at ₹960.05, touching the day’s high at ₹968.05, as of 2:18 PM on the NSE.

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